23 results · 34ms · Sources: EU EUDAMED, US FDA

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ENDOCERVICAL BLOCK NEEDLE

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526780767·LEVAMED ACTIVE ANKLE SUP SLVR L IV

ULTRAPOWER

FDA UDI
Conmed Corporation·10845854007013·ULTRAPOWER BUR, ROUND (MUSTARD) 2 MM

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0112240·Tap, 6.50mm, Cannulated, Fixed Sleeve

RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY

FDA 510(k)
FDA Class 2 ·Radiology

IOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021

BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021

BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021

BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021

HDI 5000 ULTRASOUND STANDARD SYSTEM

FDA Adverse Event
Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012

audifon

FDA UDI
audifon GmbH & Co. KG·EADF021224800831217201·BTE-TRT

audifon

FDA UDI
audifon GmbH & Co. KG·EADF021224800831317201·BTE-TRT

audifon

FDA UDI
audifon GmbH & Co. KG·EADF021224800833217201·BTE-TRT

audifon

FDA UDI
audifon GmbH & Co. KG·EADF021224800832517201·BTE-TRT

BI-METRIC HIP LATERALISED FEMORAL STEM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·March 2, 2017

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 26, 2013

SPRINT FIDELIS

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011

HIRES 90K

FDA Adverse Event
Injury ·ADVANCED BIONICS LLC·Product code MCM·March 21, 2008

JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK COMBO, REF: 85-0740, KIT, TCCC/TECC MODULE ONE SKILLS REFILL, REF: 85-1900

FDA Enforcement
Class II ·Ongoing·North American Rescue LLC.·October 8, 2025